Kornimate/medical-research-clean huggingface dataset:
preoperative ct-imaging with patient-specific computer simulation in transcatheter aortic valve replacement

Conditions: Aortic Valve Stenosis

Summary: combining routine preoperative ct imaging with patient-specific computer modelling predicts the interaction between different sizes of transcatheter aortic valve replacement devices at different implantation depths and the patient's unique anatomy (including post-implantation deformation) allowing preoperative evaluation of the risk for paravalvular leakage and conduction disorders. the objective of this randomized controlled trial is to evaluate whether pre-operative ct-imaging with advanced computer modelling and simulation (feops heartguide™) adequately predicts procedural outcomes in tavr procedures, whether it leads to changes of preoperative decisions and whether or not this leads to improved outcome in tavr procedures.


Eligibility criteria:
inclusion criteria: * primary symptomatic severe aortic valve stenosis * accepted for tavr, either by transfemoral, transsubclavian or transapical access * plan to implant one of the following transcatheter heart valves for which feops heartguide™ is available (corevalve™ evolut™ r, and evolut™ pro and evolut™ pro+ (medtronic, minnesota, usa), acurate neo™ and acurate neo 2™ (boston scientific, marlborough, ma, usa) * informed consent exclusion criteria:a potential subject who meets any of the following criteria will be excluded from participation in this study before randomization: * previous surgical aortic valve replacement * permanent pacemaker at baseline * emergency procedure * poor ct image quality (disabling computer-simulation, i.e. generation of 3d anatomical models will not be possible with poor ct image quality), for example because of motion artifacts due to the presence of other implanted devices affecting the region of interest * patient who did not agree to the informed consent and/or refused to participate * patient unable to understand the informed consent/study
influence of upper extremity vibration on spasticity and function in persons with tetraplegia

Conditions: Spinal Cord Injuries; Tetraplegia

Summary: vibration therapy is a possible alternative to drug-based treatments for spasticity following sci. research indicates that it may provide temporary relief from spasticity, but many interventions under investigation are not portable and therefore access is limited. the aim of this study is to investigate the feasibility of using a portable vibrating device to decrease ue spasticity.


Eligibility criteria:
inclusion criteria: * have sustained cervical (neurological level c1-c8) sci * any isncsci severity classification (a, b, c or d) * have therapist-reported and self-reported spasticity in the arm or hand * ability to pick up, move, and release at least one block (on the box \& blocks test) * may participate if utilizing prescription medications, including baclofen pump for control of spasticity exclusion criteria: * severe contractures of the arm/hand that limit passive movement of the elbow, wrist or fingers more than 50% of normal range of motion or presence of other orthopedic pathology that would adversely influence participation in the protocol * any implanted catheter such as but not limited to csf shunt, or the presence of pacemaker, implanted automatic internal cardioverter defibrillator (aicd, other cardiac implants and or conditions). not including baclofen pump. * severe pain or hypersensitivity of the arm/hand * current pregnancy
cerebral blood circulation in patients with posterior fossa brain tumor

Conditions: Brain Tumor

Summary: the normal cerebral blood flow is guided by factors such as cerebral autoregulation (ca) and carbon dioxide reactivity (co2r). authors have demonstrated that ca and co2r may be impaired in presence of intracranial tumors.most studies pertaining to assessment of ca and co2r in patients with brain tumors is limited to supratentorial tumors. due to their anatomic location, posterior fossa tumors result in obstruction of ventricular outflow, produce hydrocephalus and features of raise intracranial pressure (icp). it is possible that lesions in the posterior fossa may affect ca and co2r. it should also be noted that posterior fossa surgeries are carried out in positions such as prone, lateral and sitting. altered surgical positions themselves affect systemic hemodynamics which may influence cerebral blood flow; with presence of anesthetics further compromising the blood flow to the brain. understanding the homeostatic mechanisms of ca and co2r may help in deciding proper positioning of patients and maintenance of intraoperative hemodynamic. the aim of this observational study was to evaluate ca and co2r in patients with posterior fossa tumor prior to surgical decompression of the lesion.


Eligibility criteria:
inclusion criteria: * all patients with posterior fossa tumor * scheduled for elective surgery * history of recent ventriculoperitoneal shunt (within 24 hours) exclusion criteria: * previous craniotomy * patients on ventilatory support * history of cerebrovascular accident * syncope or carotid artery disease * anemia * polycythemia * patients on vasoactive medications * those suffering from medical conditions such as diabetes mellitus and hypertension.

Keywords: posterior fossa brain tumor cerebral blood flow cerebral autoregulation carbon dioxide reactivity transcranial doppler
brain network characteristics in patients with disorders of consciousness

Conditions: Disorders of Consciousness

Summary: simultaneous measurement of the three modalities, functional magnetic resonance imaging (fmri), positron emission tomography (pet) and electroencephalography (eeg) was proven to be feasible and advantageous in evaluating brain structural and functional (via fmri), metabolic (via pet) and electrophysiological (via eeg) signatures simultaneously under the same conditions. investigators use trimodal pet-fmri-eeg imaging to explore the characteristics of brain network damage in patients with disorders of consciousness(doc), assess the trajectory of consciousness recovery in a prospective observational cohort study.


Eligibility criteria:
inclusion criteria: 1. coma, vs/uws, mcs and emcs according to diagnostic criteria 2. age ≥18 years 3. written informed consent obtained exclusion criteria: 1. patients with contraindications to pet, mri, eeg examinations or inability to complete pet-fmri-eeg examinations (presence of ferromagnetic metal implants or hyperthermia) 2. hyperglycemia that is difficult to correct 3. patients with long-term use of corticosteroids 4. patients with coexisting severe systemic disease and limited life expectancy

Keywords: pet-fmri-eeg brain network coma vegetative state(vs) unresponsive wakefulness syndrome (uws) minimally conscious state(mcs) emerged from minimally conscious state(emcs)
gene therapy for tay-sachs disease

Conditions: Tay Sachs Disease; Sandhoff Disease; Late Onset Tay Sachs Disease

Summary: hypothesis: to study the natural history of tay-sachs disease and evaluate therapeutic interventions. this study is intended to work in collaboration with nct00668187 "a natural history study of hexosaminidase deficiency." because so few patients with tay-sachs disease present annually, we will maximize both research projects by enrolling patients in both studies. for this present study, we will perform retrospective medical record review to gather data. through this medical record review, we will collect biomarker analysis results, neuroimaging report data, quality-of-life questionnaire data and ophthalmology exam findings. if the subject has undergone therapy or treatment, the results will be noted.

much has been done in the past four decades to better understand, improve diagnostic measures of, and prevent hexosaminidase deficiency diseases, yet all of them - tay-sachs, sandhoff, and late onset tay-sachs (lots) - remain diseases without treatment. much work remains to be done to understand and effectively treat these diseases. to date, no comprehensive assessment of the natural history of tay-sachs or sandhoff has been undertaken. the information that is gathered through this study will characterize and describe the tay-sachs disease population as a whole, including the variability and progression of this disease. this information, in turn, will function as a point of reference against which to assess the efficacy of therapeutic interventions. therapeutic interventions may include any treatments/therapies the subject may have undergone in the past, including hematopoietic cell transplantation, and/or the administration of miglustat, acetylcysteine, or other pharmaceutical agents; and possible future gene therapies.

Eligibility criteria:
inclusion criteria: any person who has been diagnosed with a hexosaminidase deficiency disease can be included in this study. exclusion criteria: the only exclusion criteria is a desire not to participate in this study.

Keywords: hexosaminidase deficiency tay-sachs disease sandhoff disease late-onset tay-sachs disease adult-onset tay-sachs disease late onset tay sachs disease adult onset tay sachs disease retrospective hexosaminidase a activity gm2-ganglioside gangliosidoses natural history hexosaminidase
a new device for measuring of lung photoplethysmography and pulmonic arterial saturation

Conditions: Patent Ductus Arteriosus; Pulmonary Hypertension

Summary: to evaluate feasibility of photoplethysmography (ppg) of pulmonary arteries in adults children and neonates and to compare normal controls to premature newborns suffering from patent ductus arteriosus and neonates suffering from pulmonary hypertension.

this study aims to check a new device for measuring lung photoplethysmography (ppg) of pulmonary arteries by delivering light through the chest wall. the aim is to evaluate pulmonary arteries' elasticity and oxygen saturation. we will study adults children and neonates. we will study 20 healthy adults, 20 healthy children aged 2-8 years, twenty healthy neonates, 20 preterm neonates with patent ductus arteriosus (pda) and 20 preterm neonates with no pda. we will study also 20 neonates with pulmonary hypertension. each participant will be examined for 5 minutes and ppg signal will be recorded in a computer and evaluated offline later on. pulmonic saturation will be calculated from absorption difference between two wave lengths of infrared light that will be used. our hypothesis is that the mentioned clinical conditions will affect ppg signal and pulmonary arterial oxygen saturation.

Eligibility criteria:
inclusion criteria: * hemodynamic stability exclusion criteria: * hemodynamic instability
bogota school children cohort

Conditions: Nutrition; Child Health; Child Growth; Neurocognitive Development; Sexual Maturation; Infectious Morbidity; Behavior Problem

Summary: this observational study investigates the associations of nutritional indicators, biomarkers, sociodemographic conditions, and infections with child health, as well as physical, behavioral, and cognitive development. investigators recruited a random sample of 3202 children from primary public schools in bogota, colombia in february 2006 and followed them for a median of 6.5 years. investigators hypothesized that poor nutritional status at the time of recruitment in middle childhood would be related to adverse health outcomes through adolescence.


Eligibility criteria:
inclusion criteria: * primary public school enrollment in february 2006 exclusion criteria: * none
utility of endobronchial ultrasound in the investigation of suspected lung cancer.

Conditions: Lung Cancer

Summary: bronchoscopy of non visible lesions in the lung, have a low diagnostic yield. the use of endoscopic ultrasound might increase the diagnostic yield. this prospective study randomises between bronchoscopy with the use of a ultrasound miniprobe and bronchoscopy without the use of a miniprobe in clinical practice at haukeland university hospital. the study hypothesis: the use of the ultrasound miniprobe will increase the diagnostic yield of bronchoscopy in non visible lesions.

bronchoscopy is usually the primary investigation of lesions in the lung. x-ray fluorescence guides the sampling with brushing, biopsy or trans bronchial needle aspiration (tbna) if the lesion not is visible. ct guided trans-thoracic sampling will be performed if a the sample is non representative. this will delay the diagnosis, and trans-thoracic sampling has a higher risk of pneumothorax. the use of a ultrasound miniprobe might increase the diagnostic yield of bronchoscopy in non visible lesions. the ultrasound probe in a guide sheath is advanced to the lesion with use of x-ray fluorescence. when the lesion is visualised the miniprobe is removed and sampling is performed with tbna, biopsy and brushing through the guide sheath. if rapid on site cytoevaluation is negative, new tbna is performed. previous trials have shown a diagnostic yield without ultrasound between 40-50% and with ultrasound between 60-80%. the studies with ultrasound have been performed by "super specialists". this study will evaluate bronchoscopy with the use of ultrasound miniprobe in clinical practice without "super specialists". it is a prospective randomised trial.

Eligibility criteria:
inclusion criteria: * all patients with lesions suspicious of malignancy in the lung. exclusion criteria: * patients with lesions assumed to be visible by bronchoscopy. * later proven visible lesion by bronchoscopy. * patients not able to be investigated by bronchoscopy.

Keywords: endobronchial ultrasonography fluoroscopy guide sheath peripheral pulmonary lesion transbronchial biopsy
comparison of procalcitonin level in normal population and in chronic kidney disease patients who don't have infection

Conditions: Chronic Kidney Disease Patients Who Don't Have Infection

Summary: chronic kidney disease (ckd) is a life threatening condition with high risk of pre-term death and need for dialysis. it is defined as kidney damage that has continued for more than 3 months as characterized by structural or functional abnormalities of the kidney, with or without decreased glomerular filtration rate (gfr). it is also defined as gfr \< 60ml/min/1.73 m2 for more than 3 months, with or without structural kidney damage. the pct level in healthy individual without infection is below the limit of detection (0.01 ng/ml), and it is significantly elevated under the stimulation of pathogens. however, due to the pre-existing endogenous inflammation that occurs in ckd patients and the impaired kidney clearance, the reference range that applies to the general population may not be appropriate for diagnosing infections in ckd patients. more recently, debate has continued regarding whether the pct level is increased in ckd patients without infection, and the optimal reference for ckd patients remains undetermined


Eligibility criteria:
inclusion criteria: * chronic kidney disease patients. * esrd patients exclusion criteria: any condition of infection or sepsis such as : * fever * increased tlc above normal * tachycardia * tachypnea * disturbed conscious level
pulmonary artery denervation clinical study using the gradient denervation system in heart failure patients with pulmonary hypertension group 2 (prevail-ph2 ous study)

Conditions: Pulmonary Hypertension

Summary: characterize the impact of pulmonary artery denervation on the quality of life in heart failure patients with group 2 pulmonary hypertension

the gradient denervation system delivers ultrasound ablation to planned locations in the pulmonary artery to down-regulate the sympathetic nervous drive. the system includes a sterile, single-use catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.

Eligibility criteria:
inclusion criteria: * mean pulmonary artery pressure (mpap) \>20 mmhg at rest * pulmonary vascular resistance (pvr) ≥ 3wu at rest * pulmonary capillary wedge pressure \> 15 mmhg (at rest) or \> 18 with passive leg raise * nyha class ii or iii * glomerular filtration rate (gfr) ≥ 25 ml/min exclusion criteria: * unwilling to provide informed consent or complete follow-up assessments * life expectancy of \< 2 years * inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel * unable to tolerate right heart catheterization * severe aortic, mitral or pulmonary valve regurgitation * clot or thrombus in any potential target ablation zone (right, left or main pulmonary artery) * systemic infection or localized infection/rash at planned access site at time of procedure * crt, icd, pacemaker or other interventional cardiac procedure (except rhc) within the last 3 months
vildagliptin versus dapagliflozin on glucagon

Conditions: Type 2 Diabetes

Summary: the aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2 diabetes and whether this is associated with effects on glucose homeostasis.

the aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2 diabetes and whether this is associated with effects on glucose homeostasis. subjects will therefore be treated with vildagliptin or dapagliflozin as add-on to metformin for two weeks followed by a meal test in which glucagon levels will be determined.

Eligibility criteria:
inclusion criteria: 1. written consent has been given. 2. patients with type 2 diabetes treated with a stable dose of metformin during the last three months 3. age 20-70 years. 4. hba1c 6.5-8.5% (48-67 mmol/mol) at visit 1. 5. ability to complete the study exclusion criteria: 1. use of other glucose-lowering therapy than metformin within three months prior to visit 1. 2. a history of any secondary forms of diabetes, e.g., cushing's syndrome and acromegaly. 3. type 1 diabetes, positive gad antibodies 4. estimated glomerular filtration rate \<60 ml/min 5. acute infections which may affect blood glucose control within 4 weeks prior to visit 1 6. any history of recent (\<2 weeks) recurrent or severe hypoglycemic episodes. 7. any history of acute pancreatitis 8. any history of anaphylaxis, angioedema, and exfoliative skin conditions including stevens-johnson syndrome. 9. liver disease such as cirrhosis or chronic active hepatitis 10. history of coronary heart disease or heart failure class iii or iv 11. donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks. 12. treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (\> 7 consecutive days of treatment) within 8 weeks prior to visit 1. 13. use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study 14. hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core
effects of a training intervention after thoracoabdominal oesophagus surgery

Conditions: Oesophagus Cancer

Summary: this study evaluates the effect of a training intervention after thoracoabdominal resection of the oesophagus. half of the patients scheduled for thoracoabdominal oesophagus surgery were randomized to an intervention group while the other half a control group.

it is well known that thoracoabdominal oesophageal resection for cancer is a procedure with high risks for complications. earlier trials have shown that respiratory restrictions persist after the operation as well as lower physical function, range of motion in the rib-cage and limitations in activities in daily living. there are, however, only two clinical studies that evaluate postoperative breathing exercises and none evaluating any other rehabilitation interventions. in other types of extensive surgery that may affect mobility with trauma to muscles and bone structures in the thorax and thoracic spinal column, there is strong evidence that speaks for an active rehabilitation approach in favour of a less active one. the intervention evaluated was a rehabilitation program including exercises to restore lung function, range of motion in the thoracic spine and shoulders and strength exercises for the back extensors, shoulders and legs.

Eligibility criteria:
inclusion criteria: * patients scheduled for thoracoabdominal oesophageal resection * ability to perform 90 w during a sub-maximal bicycle test * ability to speak swedish exclusion criteria: * serious untreated cardiac disease that may be critical * musculoskeletal or neurological disease or trauma affecting respiration or range of motion in the rib cage

Keywords: pain range of motion quality of life
an observational/non-interventional, study of ns3/4a protease and ns5a protein of hepatitis c virus in brazilian participants with chronic hcv infection

Conditions: Hepatitis C Virus

Summary: the purpose of this study is to describe the genetic diversity of hepatitis c virus (hcv) ns3/4a protease and ns5a protein of hcv in participants with chronic disease naive-drug or previously failed to double therapy (peg-interferon and ribavirin) and to identify the frequency of natural polymorphisms in hcv ns3/4a protease and ns5a protein that are associated with direct-acting antivirals (daas)-resistance.

this is a multicenter, observational/non-interventional, cross-sectional study to describe the genetic diversity of and to identify the natural polymorphisms in hcv ns3/4a protease and ns5a protein of hepatitis c virus in brazilian participants with chronic hcv infection. brazilian participants with genotype 1 hcv infection treatment naive participants or previously failed to double therapy (peg-interferon-α and ribavirin) will be included in the trial and will constitute the trial population.

Eligibility criteria:
inclusion criteria: * participants mono infected with chronic hepatitis c infection (genotype 1), including naive patients or previously failed to double therapy (peg-interferon-α and ribavirin) * there is no restriction on fibrosis stage or clinical liver disease * there is no restriction for comorbidities * male or female participants with age \>=18 years exclusion criteria: * participants failed to triple therapy using protease inhibitors * participants with co-infections (i.e. human immunodeficiency virus, hepatitis b virus) * participants that are not agree to sign the written informed consent * participants is taking part in an interventional clinical trial with an investigational agent (i.e. non-commercialized agent) or in an interventional clinical trial sponsored by johnson \& johnson

Keywords: hepatitis c virus